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CONCORDE™ ClearMIS Discectomy DeviceSurgical Technique

Contents

CONCORDE™ Clear MIS Discectomy Device Surgical Technique DePuy Synthes 1

MR Information

This device has not been evaluated for safety and compatibility in the MR environment.

This device has not been tested for heating or migration in the MR environment.

Product Overview

Surgical Technique

Packaging, Handling, & Sterilization

Catalog

Indications and Contraindications

Introduction 2

Features and Benefits 3

Set Up 4

Annulotomy and Initial Disc Dissection 5

Initial Disc Distraction & Preparation of Disc Space 6

Final Disc Preparation & Endplate Clearing 7

11

Instruments 12

13

2 DePuy Synthes CONCORDE™ Clear MIS Discectomy Device Surgical Technique

Product Overview

Introduction

The CONCORDE™ Clear MIS Discectomy Device is an

orthopedic manual hand held surgical instrument for use

in performing a discectomy in open and minimally

invasive spinal procedures. It is composed of a distal

cutting head with serrated cutting edges, a distal guard,

and a hollow shaft that connects the cutting head to the

handle proximally. The handle is hollow and serves as

a reservoir to collect extracted disc tissue. The

CONCORDE Clear Device has a port for connecting to a

standard suction tube, which is attached to standard

hospital wall or pump suction. Different tip angles and

working lengths are available to facilitate disc removal

and accommodate approaches.


Features and Benefits

• Variable Cutting Tip Sizes

- Available in angles of 15°, 30° & 40° and multiple

lengths to accommodate various approaches.

- Cutting edges shear disc material from the endplates

while the suction draws disc material into the tube.

• Tip Guard

Impedes penetration of the anterior annulus and

minimizes clogging of the tip.

• 360° Wall Suction Connection

Allows for user-friendly instrument movement.

• Finger-Controlled Suction Valve

Places on/off control of suction in surgeon’s control.

• Transparent Handle to Visualize Collection

of Disc Material

Provides visualization of collected disc material.

Disc Removal & Endplate Preparation with One Tool

Tip Guard

Variable Cutting

Tip Sizes

360° Wall

Suction

Connection

Transparent Handle to

Visualize Collection

Compatible

with Standard

Hospital Suction

Finger-Controlled

Suction Valve


Surgical Technique

Step 1

Setup:

1. Carefully select the correct size of the

CONCORDE Clear MIS Discectomy Device for desired

working length, both cutter diameter and tip bend

angle. Failure to do so could result in tissue damage.

2. Carefully inspect the CONCORDE Clear Device package

prior to use for any breach of the sterile barrier or

damage to the contents and ensure the device has not

expired. Failure to do so could result in patient

infection.

3. Connect a standard suction tube to a dedicated suction

canister with a standard vacuum source (wall or pump)

(Fig.1). Please follow Standard Hospital/OR protocol and

aseptic techniques when attaching the suction tubing.

4. Regulate vacuum pressure to be in the range of

300 mm Hg to 600 mm Hg.

Warning: • Use of the device with vacuum levels above

600 mmHg may result in residual suction at

device tip while suction control valve is open,

increasing the risk of injury to vascular or

nervous tissues and related patient injury.

5. Fill a small basin with approximately 300-500 cc of

sterile saline.

Step 2

Device Preparation

1. Attach the elbow connector to both the suction tube

and device (Fig. 2).

Precaution: • Ensure complete connection of device to suction

tube, canister, and wall vacuum or pump prior

to use.

• Do not attach device to hospital air-line. Failure to do so could result in patient injury.

2. Verify device suction by inserting the device tip into the

basin of sterile saline and activating suction. Cover the Suction Control Valve hole to activate suction at the

device tip (Fig. 3).

Fig. 1

Fig. 2

Fig. 3


Surgical Technique

Step 3

Annulotomy and Initial Disc Dissection

1. Insert a nerve root retractor to protect neural

structures. Care should be taken to gently retract and

protect the exiting nerve root and lateral part of the

central thecal sac. A dissector or nerve root retractor is

used to ensure the protection of these neural

structures at every step of the procedure (Fig. 4).

2. Perform an annulotomy on the target disc to create a

window into the disc space (Fig. 5).

After the annulotomy, a pituitary rongeur is used to

initially remove disc tissue in order to clear an initial

space for the tip of the CONCORDE Clear Device (Fig. 6).

Fig. 4

Fig. 5

Fig. 6


Surgical Technique

Step 4

Initial Disc Distraction & Preparation of Disc Space

1. Insert the tip of the CONCORDE Clear Device into the

disc space until the laser markings at the distal end of

the device tip are fully within the disc space. (Figs. 7 & 8)

Use a spreader if additional room is needed to safely insert the device.

2. Cover the Suction Control Valve hole to activate

suction at the device tip. (Fig. 9)

Warnings: • Do not insert into, or remove the device from the

intervertebral disc with the tip suction ON

(suction tubing connected to device with suction

control valve closed or finger covering the suction

control valve). Failure to comply could result in

possible injury to nervous or vascular tissues.

• The device should never be in direct contact with

any vascular or nervous tissues. The tip suction

should be OFF when the cutting head is in close

proximity to any vascular or nervous tissues.

Failure to comply may result in injury to these

tissues and related patient injury.

• Do not use excessive force when using the device.

Failure to comply may result in device breakage,

malfunction, or patient injury.

Tips: • Observe depth markers to estimate the position

of the device tip within the disc space.

• Use fluoroscopy to assist with determining the location of device tip within the disc space.

• Confirm vacuum source is ON before performing discectomy

• The tip orientation is aligned with the location of the suction control valve.

Precautions:

• Use visual modalities such as fluoroscopy or

direct visualization to ensure that the device tip

is not accidentally placed outside of the disc

space. Failure to do so could result in possible

injury to nervous or vascular tissues.

Fig. 7

Fig. 8

Fig. 9


Surgical Technique

Step 5Final Disc Preparation & Endplate Clearing

Nucleotomy Step:

a) With the CONCORDE Clear Device tip approximately

parallel to the upper or lower endplate, gently push the

tip forward with pressure against the endplate or

annulus to remove target nucleus.

b) Repeat this in a series of push and pull motions at

different axial-plane angles to expand the cavity within

the disc space. (Fig. 10)

Tips:

• When using the 15º tip, it is recommended to

point the tip both laterally and medially to

reach more target tissue. The device should be

removed from the disc space before adjusting

tip orientation from medial to lateral.

• Fluoroscopy can be used to verify the location

of the device within the disc space.

Additionally, laser markings along the shaft of

the device provides an estimate of the length of

the device shaft in the disc space.

Precautions:

• Caution should be taken to avoid the device tip

fully penetrating the annulus contralateral to the

annulotomy. Failure to do so could result in

possible injury to nervous, vascular or soft tissues.

• Use visual modalities such as fluoroscopy or

direct visualization to ensure that the device tip

is not accidentally placed outside of the disc

space. Failure to do so could result in possible


• If the device gets clogged with tissue, quickly

insert and remove the device in a bowl of sterile

saline several times with device suction

activated. Alternatively, use the stylet provided

in the device package to remove the clog by

inserting the stylet into the tip of the device to

push clog towards the handle of the device.

Caution should be taken to avoid glove contact

with the cutter tip. Failure to do so could result

in possible injury to the user.

Fig. 10


Surgical Technique

Step 6

Endplate Cartilage Removal Step:

Once the bulk of the nucleus in the target area is

removed, apply tip pressure to the endplate and gently

scrape the cutting tip in a parallel direction to the endplate

where there is remaining cartilage to remove (Fig. 11).

Repeat this at various medial to lateral angles to

thoroughly remove disc material from the caudal endplate

of the superior vertebral body and the rostral endplate of

the inferior vertebral body.

Warning: • Do not repeatedly use device on the vertebral

endplates once cartilage has been removed as

overuse may cause damage to the endplate bone.

Optional Step

Remove excess tissue and target inner annulus by gently

sweeping the device tip against the inner annulus to

remove any remaining target tissue (Fig. 12).

Fig. 11

Fig. 12


Step 7

When the discectomy is complete, turn suction off at tip

and remove CONCORDE Clear Device from the disc space

(Fig. 13).

Warning:

• Do not insert into, or remove the device from the

intervertebral disc with the tip suction ON (suction

tubing connected to device with suction control

valve closed or finger covering the suction control

valve). Failure to do so could result in possible


Step 8

Use a Penfield or preferred instrument to confirm that the

discectomy and endplate preparation is complete for the

reachable target disc area (Fig. 14). If not complete,

reinsert the device and complete the discectomy.

Step 9

The cap can be removed to access tissue in the handle by

gently prying it from the handle (Fig. 15). Once the reservoir has been emptied, the cap can be reattached to

the handle and the device can continue to be used.

Surgical Technique

Fig. 13

Fig. 14

Fig. 15


Step 10

For procedures requiring an additional device, repeat

steps 1 through 8 to complete the discectomy including

endplate preparation.

Tips: • The elbow connector can remain attached to the

hospital suction and be re-connected to the new

device during the same procedure.

• After using device, evacuate sterile saline

through device to purge the device so it does not

clog if used at a later time during the procedure.

• When using the 30° or 40° tip, it is only

recommended to point the tip towards the

contralateral side.

Step 11

Dispose of device(s) according to local regulations.

Surgical Technique

Fig. 16


• The sterile packaging should be inspected for damage

and expiration date prior to use. Inspect the package

prior to use for any sterile barrier breach or damage to

the contents. Do not use if the package is damaged or if

you suspect that sterility has been compromised. Do not

reuse or re-sterilize the device.

• The device is supplied sterile. It has been sterilized by

gamma radiation.

• If packaging or sterile barrier is breached, or there is

damage to the contents of the packages, do not use

and contact your DePuy Synthes Spine representative.

Packaging, Handling, and Sterilization


Part Number Product Description

163005515 CONCORDE Clear Device 15° × 5 mm



163010515 CONCORDE Clear Device, Long 15° × 5 mm

Product Catalog


Indications and Contraindications

Indications for Use

The CONCORDE Clear MIS Discectomy Device is indicated for spinal

discectomy procedures for the cutting and removal of soft and hard

tissue in open and minimally invasive spinal surgeries.

Contraindications

Contraindications for the CONCORDE Clear MIS Discectomy Device

include but are not limited to patients with:

• Active local or systemic infection

• Allergy to any device materials, including stainless steel

• Discitis

• Irreversible bleeding disorder or coagulopathy

• Pregnancy

• Severe Osteoporosis

Warnings

• The device should only be used by physicians with experience and

training in spine surgery.

• Do not use excessive force when using the device. Failure to comply

may result in device breakage, malfunction, or patient injury.

• Never bend device shaft before or during procedure. Failure to comply

may result in device breakage, malfunction, or patient injury.

• Do not insert into, or remove the device from the intervertebral disc

with the tip suction ON (suction tubing connected to device with

suction control valve closed or finger covering the suction control

valve). Failure to do so could result in possible injury to nervous or

vascular tissues.

• The device should never be in direct contact with any vascular or

nervous tissues. The tip suction should be OFF when the cutting head

is in close proximity to any vascular or nervous tissues. Failure to

comply may result in injury to these tissues and related patient injury.

• Use of the device with vacuum levels above 600 mmHg may result in

residual suction at device tip while suction control valve is open,

increasing the risk of injury vascular or nervous tissues and related

patient injury.

• Do not repeatedly use device on the vertebral endplates once cartilage

has been removed as overuse may cause damage to the endplate

bone.

• For single procedure use only. Do not reuse, reprocess or re-sterilize.

Failure to comply may result in device breakage, malfunction, the use

of a non-sterile or contaminated System, or patient injury.

• The components of the CONCORDE Clear MIS Discectomy Device are

designed to be used in combination and function as a single unit.

Failure to properly follow instructions may lead to improper

functioning of the device and may cause patient injury.

Precautions

• Caution should be taken to avoid the device tip fully penetrating the

annulus contralateral to the annulotomy. Failure to do so could result

in possible injury to nervous, vascular or soft tissues.

• Use visual modalities such as fluoroscopy or direct visualization to

ensure that the device tip is not accidentally placed outside of the disc

space. Failure to do so could result in possible injury to nervous or

vascular tissues.

• When nervous tissue is near the pathway to the disc space, use a nerve

root retractor to protect the nervous tissue.

• When removing the sterile device, socket, and stylet from the

packaging, be aware that the device, socket, and stylet are separate

items within the same packaging.

• Ensure complete connection of device to suction tube, canister, and

wall vacuum or pump prior to use.

• If the device gets clogged with tissue, quickly insert and remove the

device in a bowl of sterile saline several times with device suction

activated. Alternatively, use the stylet provided in the device package

to remove the clog by inserting the stylet into the tip of the device to

push clog towards the handle of the device. Caution should be taken

to avoid glove contact with the cutter tip. Failure to do so could result

in possible injury to the user.

Possible Adverse Effects

As with all major surgical procedures, risks, side effects and adverse

events can occur. While many possible reactions may occur, some of the

most common may include:

• Problems resulting from anesthesia and patient positioning (e.g.

nausea, vomiting, dental injuries, neurological impairments, etc.),

thrombosis, embolism, infection, excessive bleeding, iatrogenic vital

organ, neural and vascular injury, including spinal cord, dural tear or

spinal fluid leak. Functional impairment of the musculoskeletal system,

allergy/hyper-sensitivity reactions, ongoing pain; damage to adjacent

bones which may interfere fusion; damage to soft tissue, including

swelling or abnormal scar formation.

Magnetic Resonance (MR) Compatibility

• The CONCORDE Clear MIS Discectomy Device has not been evaluated

for safety and compatibility in the MR environment. The device has not

been tested for heating or migration in the MR environment.

0086

DePuy Spine Inc.

325 Paramount Drive

Raynham, MA 02767

USA

Medos International SARL

Chemin-Blanc 38

2400 Le Locle

Switzerland

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